The effect of fibrinogen concentrate on postoperative blood loss: A systematic review and meta-analysis of randomized controlled trials

Ng, Ka Ting; Yap, Jasmine Li Ling; Kwok, Pei En

doi:10.1016/j.jclinane.2020.109782

Cited by 8 publications

(8 citation statements)

References 37 publications

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“… 37 Furthermore, a 2020 meta-analysis of 13 randomized trials in postoperative blood loss in adult surgical patients reported no notable differences in AEs, including TEEs, with fibrinogen concentrate versus placebo. 81 …”

Section: Discussionmentioning

confidence: 99%

Long-Term Safety Analysis of a Fibrinogen Concentrate (RiaSTAP^®/Haemocomplettan^® P)

Rahe-Meyer,

Neumann,

Schmidt

et al. 2024

Clin Appl Thromb Hemost

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Fibrinogen concentrate treatment is recommended for acute bleeding episodes in adult and pediatric patients with congenital and acquired fibrinogen deficiency. Previous studies have reported a low risk of thromboembolic events (TEEs) with fibrinogen concentrate use; however, the post-treatment TEE risk remains a concern. A retrospective evaluation of RiaSTAP®/Haemocomplettan® P (CSL Behring, Marburg, Germany) post-marketing data was performed (January 1986–June 2022), complemented by a literature review of published studies. Approximately 7.45 million grams of fibrinogen concentrate was administered during the review period. Adverse drug reactions (ADRs) were reported in 337 patients, and 81 (24.0%) of these patients experienced possible TEEs, including 14/81 (17.3%) who experienced fatal outcomes. Risk factors and the administration of other coagulation products existed in most cases, providing alternative explanations. The literature review identified 52 high-ranking studies with fibrinogen concentrate across various clinical areas, including 26 randomized controlled trials. Overall, a higher number of comparative studies showed lower rates of ADRs and/or TEEs in the fibrinogen group versus the comparison group(s) compared with those that reported higher rates or no differences between groups. Post-marketing data and clinical studies demonstrate a low rate of ADRs, including TEEs, with fibrinogen concentrate treatment. These findings suggest a favorable safety profile of fibrinogen concentrate, placing it among the first-line treatments effective for managing intraoperative hemostatic bleeding.

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Section: Discussionmentioning

confidence: 99%

Long-Term Safety Analysis of a Fibrinogen Concentrate (RiaSTAP^®/Haemocomplettan^® P)

Rahe-Meyer,

Neumann,

Schmidt

et al. 2024

Clin Appl Thromb Hemost

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“…However, some studies have provided evidence of the thromboembolic potential of tranexamic acid 36 37. In contrast, fibrinogen is not associated with higher thromboembolic risk repeatedly 38. It is appropriate to study fibrinogen concentrate to see if it has the same positive properties as tranexamic acid without possible side effects.…”

Section: Discussionmentioning

confidence: 99%

Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery (EFISS): a study protocol of two-arm, randomised trial

Vrbica,

Hudec,

Hrdy

et al. 2023

BMJ Open

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IntroductionFibrinogen is one of the essential coagulation factors. Preoperative lower plasma fibrinogen level has been associated with higher blood loss. Scoliosis surgery presents a challenge for the anaesthetic team, one of the reasons being blood loss and transfusion management. Recently, the prophylactic fibrinogen administration has been a debated topic in various indications. It has been described for example, in urological or cardiovascular surgery, as well as in paediatrics. This pilot study is focused on verifying the feasibility of potential large randomised trial and verifying the safety of prophylactic fibrinogen administration in paediatric scoliosis surgery.Methods and analysisA total of 32 paediatric patients indicated for scoliosis surgery will be recruited. Participants will be randomised into study groups in a 1:1 allocation ratio. Patients in the intervention group will receive prophylactic single dose of fibrinogen, in addition to standard of care. Patients in the control group will receive standard of care without study medication prior to skin incision. The primary aim is to assess the safety of prophylactic fibrinogen administration during scoliosis surgery in children, the incidence of any adverse events (AEs) and reactions will be monitored during participation in the study. The secondary objective is to investigate the additional safety information, feasibility and efficacy of a prophylactic fibrinogen administration. The incidence of AEs and reactions according to selected adverse events of special interest will be monitored. All collected data will be subjected to statistical analysis according to a separate statistical analysis plan.Ethics and disseminationThis trial follows the applicable legislation and requirements for good clinical practice according to the International Conference on Harmonisation E6(R2). All essential trial documents were approved by the relevant ethics committee and national regulatory authority (State Institute for Drug Control) and their potential amendments will be submitted for approval.Trial registration numberNCT05391412.

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“…21 As high fibrinogen concentration enhances clot firmness, restoration of depleted reserves has been introduced in clinical practice as a cost effective treatment able to decrease postoperative bleeding and transfusion. In a meta-analysis of 13 RCTs, Ng et al 22 observed that fibrinogen concentrate supplementation in adult surgical patients minimises postoperative bleeding in cardiac surgery, 23,24 urology, 25 liver transplantation, 26 and orthopaedics. 27 Notably, no patients undergoing open TAAA repair were included in the metaanalysis, albeit this surgery can be considered an archetype when analysing factors and therapies related to perioperative haemorrhage.…”

Section: Discussionmentioning

confidence: 99%

Trigger and Target for Fibrinogen Supplementation Using Thromboelastometry (ROTEM) in Patients Undergoing Open Thoraco-Abdominal Aortic Aneurysm Repair

Monaco

Barucco

Licheri

et al. 2021

European Journal of Vascular and Endovascular Surgery

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The effect of fibrinogen concentrate on postoperative blood loss: A systematic review and meta-analysis of randomized controlled trials

Cited by 8 publications

References 37 publications

Long-Term Safety Analysis of a Fibrinogen Concentrate (RiaSTAP^®/Haemocomplettan^® P)

Long-Term Safety Analysis of a Fibrinogen Concentrate (RiaSTAP^®/Haemocomplettan^® P)

Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery (EFISS): a study protocol of two-arm, randomised trial

Trigger and Target for Fibrinogen Supplementation Using Thromboelastometry (ROTEM) in Patients Undergoing Open Thoraco-Abdominal Aortic Aneurysm Repair

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The effect of fibrinogen concentrate on postoperative blood loss: A systematic review and meta-analysis of randomized controlled trials

Cited by 8 publications

References 37 publications

Long-Term Safety Analysis of a Fibrinogen Concentrate (RiaSTAP®/Haemocomplettan® P)

Long-Term Safety Analysis of a Fibrinogen Concentrate (RiaSTAP®/Haemocomplettan® P)

Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery (EFISS): a study protocol of two-arm, randomised trial

Trigger and Target for Fibrinogen Supplementation Using Thromboelastometry (ROTEM) in Patients Undergoing Open Thoraco-Abdominal Aortic Aneurysm Repair

Contact Info

Product

Resources

About

Long-Term Safety Analysis of a Fibrinogen Concentrate (RiaSTAP^®/Haemocomplettan^® P)

Long-Term Safety Analysis of a Fibrinogen Concentrate (RiaSTAP^®/Haemocomplettan^® P)